JP7203181B2 - port tunneling system - Google Patents

Description

The present disclosure relates to port tunneling systems.

A standard procedure to place a vascular access device such as a port requires two incisions. a first incision near the clavicle used to introduce a catheter into the superior vena cava for vascular access; and a second incision below the . Creation and closure of port pockets constitutes the majority of the procedure (approximately 42%) and increases the risk of tissue trauma and infection at the site of the second incision. Additionally, the need for a second incision increases the likelihood of scarring.

U.S. Patent Application Publication No. 2004/193119

Provided herein are port tunneling systems and methods that address the above.

Provided herein, in some embodiments, is a system that includes a streamlined port and a port tunneler. The port includes a septum and a stabilizing element. A septum is disposed over the cavity within the body of the port, and the septum is configured to receive a needle therethrough. The stabilizing element is configured to stabilize the port in vivo and maintain needle access to the septum. A port tunneler includes an adapter and a release mechanism. The adapter is at the tip of the port tunneler. The adapter is configured to securely hold the port during subcutaneous tunneling of the port from an incision site to an implantation site for the port. A release mechanism is configured to release the port from the adapter at the implantation site for the port.

In such embodiments, the stabilizing element is the inflatable portion of the port. The inflatable portion includes an unexpanded state that gives the port a contour configured to subcutaneously tunnel the port from an incision site to an implantation site for the port. The expandable portion further includes an expanded state configured to stabilize the port against rotation about the central axis of the port in vivo, thus maintaining needle access to the septum.

In such embodiments, the inflatable portion imparts a triangular prism-like shape to at least a portion of the port when in the inflated state. The cross section of such a triangular prism shape is triangular.
In such embodiments, the expandable portion is configured to expand with one or more fluids, one or more polymers, or combinations thereof. The one or more fluids are selected from mixtures including pure fluids and solutions.

In such embodiments, the expandable portion is configured to expand by introducing a solution comprising at least one polymer precursor, wherein the at least one polymer precursor is at least Form a polymer with one other polymer precursor.

In such embodiments, a swellable polymer is disposed within the expandable portion. The expandable portion is formed by a combination of introducing water or saline to expand the expandable portion and swelling the swellable polymer with water or saline to further expand the expandable portion. configured to inflate.

In such embodiments, the port tunneler further includes an inflation lumen fluidly connected to the inflatable portion for inflating the inflatable portion with one or more fluids.
In such embodiments, the port tunneler further includes a hub at the proximal end of the port tunneler. The hub is configured to fluidly connect with the syringe to deliver one or more fluids to the inflatable portion through the inflation lumen.

In such embodiments, the port further includes a one-way valve configured to close the inflatable portion when the release mechanism releases the port from the port tunneler.
In such embodiments, the stabilizing elements are at least pairs of legs. The pair of legs are configured to stabilize the port against rotation about the central axis of the port in vivo, thus maintaining needle access to the septum.

In such embodiments, the pair of legs are configured to assume a deployed state when the release mechanism releases the port from the port tunneler. The adapter is configured to retain the proximal portion of the port, including the leg pair, in the folded state of the leg pair prior to releasing the port from the port tunneler with the release mechanism.

In such embodiments, the stabilizing element is the winged shape of the port. The winged shape is configured to stabilize the port against rotation about its central axis in vivo, thus maintaining needle access to the septum.

In such embodiments, the stabilizing element is an inflatable portion of the port, a pair of legs, a winglet shape of the port, or a combination thereof. The inflatable portion includes an unexpanded state that gives the port a contour configured to subcutaneously tunnel the port from an incision site to an implantation site for the port. The expandable portion further includes an expanded state configured to stabilize the port against rotation about the central axis of the port in vivo, thus maintaining needle access to the septum. Each of the pair of legs and the winged shape are also configured to stabilize the port against rotation about the central axis of the port in vivo, thus maintaining needle access to the septum.

In such embodiments, the system further includes an installation tool. The installation tool is configured to hold at least a distal portion of the port for connecting a catheter to the proximal portion of the port. The installation tool is further configured to facilitate installation of the port within the adapter at the tip portion of the port tunneler.

Also provided herein, in some embodiments, is a port tunneler that includes an adapter and a release mechanism. The adapter is at the tip of the port tunneler. The adapter is configured to securely hold the port during subcutaneous tunneling of the streamlined port from the incision site to the implantation site for the port. A release mechanism is configured to release the streamlined port from the adapter at the implantation site for the port.

In such embodiments, the port tunneler further includes an inflation lumen. The inflation lumen is configured to fluidly connect to the inflatable portion of the streamlined port for inflating the inflatable portion with one or more fluids.

In such embodiments, the port tunneler further includes a hub at the proximal end of the port tunneler. The hub is configured to fluidly connect with the syringe to deliver one or more fluids to the inflation lumen.

In such embodiments, the adapter is further configured to retain at least the pair of legs of the streamlined port in the folded state of the pair of legs.
In such embodiments, the adapter is further configured to retain a streamlined port having a winged shape.

In such embodiments, the port tunneler further includes a handle on the proximal portion of the port tunneler. The handle includes a release button of a release mechanism, the release mechanism configured to release the streamlined port from the adapter when the release button is depressed.

In such embodiments, the port tunneler is configured to be positioned within the sheath alongside the catheter connected to the streamlined port when the port is positioned within the adapter.
Also provided herein, in some embodiments, is a streamlined port that includes a septum and a stabilizing element. A septum is disposed over the cavity within the body of the port, and the septum is configured to receive a needle therethrough. The stabilizing element is configured to stabilize the port in vivo and maintain needle access to the septum. The port further includes contours configured to subcutaneously tunnel the port on the port tunneler from the incision site to the implantation site for the port.

In such embodiments, the stabilizing element is the inflatable portion of the port. The expandable portion includes an unexpanded state that contributes to a contour configured to subcutaneously tunnel the port from the incision site to the implantation site for the port. The expandable portion further includes an expanded state configured to stabilize the port against rotation about the central axis of the port in vivo, thus maintaining needle access to the septum.

In such embodiments, the inflatable portion imparts a triangular prism-like shape to at least a portion of the port when in the inflated state. The cross section of such a triangular prism shape is triangular.
In such embodiments, the port further includes a one-way valve configured to close the inflatable portion upon release of the port from the port tunneler.

In such embodiments, the stabilizing elements are at least pairs of legs. The pair of legs are configured to stabilize the port against rotation about the central axis of the port in vivo, thus maintaining needle access to the septum.

In such embodiments, the stabilizing element is the winged shape of the port. The winged shape is configured to stabilize the port against rotation about its central axis in vivo, thus maintaining needle access to the septum.

Herein, in some embodiments, loading a streamlined port onto an adapter at a distal portion of a port tunneler; inserting the port into an incision at a first body location; A method is also provided that includes tunneling subcutaneously to an implantation site at a second body location using a port tunneler, and releasing the port from the adapter with a release mechanism of the port tunneler. The port tunneler adapter is configured to hold the port stabilizing element in a folded state. Releasing the port from the adapter allows the port's stabilizing element to assume an expanded state to stabilize the port in vivo and maintain needle access to the port's septum.

In such embodiments, the method comprises making an incision at the first body location, the incision being sized such that no more than one or two sutures are required to close the incision. , further comprising the step of:

In such embodiments, the method further includes implanting the cardiac end of the catheter within the superior vena cava.
In such embodiments, the method further includes connecting the port end of the catheter to the port and locking the catheter over the port with a catheter lock prior to loading the port onto the adapter of the port tunneler. The step of connecting and locking the port end of the catheter onto the port either precedes or follows the step of implanting the cardiac end of the catheter within the superior vena cava.

In such embodiments, the method further includes removing the port from the second body location with the port retriever. The port retriever includes a hook for withdrawing the port from the second body location through a hole in the tip of the port.

In such embodiments, the method further includes removing the port from the second body location with one or more standard surgical instruments.
In some embodiments herein, the steps of loading a streamlined port within the proximal end of the sheath; tunneling the port to an implantation site at a second intracorporeal location at the distal end of the sheath; and releasing the port from the . The sheath is configured to hold the stabilizing elements of the port in a folded state along the length of the sheath. Releasing the port from the sheath allows the port's stabilizing element to assume an expanded state to stabilize the port in vivo and maintain needle access to the port's septum.

In such embodiments, the method comprises the steps of making an incision at a first body location, establishing a pathway to a second body location, and sequentially dilating the pathway with successive sets of dilators. Including further. The incision is sized such that no more than one or two sutures are required to close the incision. Following dilation with the dilator set, the sheath is left in place for loading of the streamlined port.

In such embodiments, the method further includes implanting the cardiac end of the catheter within the superior vena cava.
In such embodiments, the method further includes, before loading the streamlined port within the sheath, connecting the port end of the catheter to the port and locking the catheter over the port with a catheter lock. The step of connecting and locking the port end of the catheter onto the port either precedes or follows the step of implanting the cardiac end of the catheter within the superior vena cava.

In such embodiments, the method further includes removing the port from the second body location with the port retriever. The port retriever includes a hook for withdrawing the port from the second body location through a hole in the tip of the port.

In such embodiments, the method further includes removing the port from the second body location with one or more standard surgical instruments.
In such embodiments, the method further includes removing the port from the second intracorporeal location with another sheath along the path from the first intracorporeal location to the second intracorporeal location.

These and other features of the concepts presented herein can be better understood with reference to the drawings, the specification and the appended claims.

1 provides a schematic diagram illustrating a system including a streamlined port and a port tunneler, according to some embodiments; FIG. 2 provides a schematic diagram showing multiple streamlined ports according to various embodiments; FIG. FIG. 2 provides a schematic diagram showing an end view of a streamlined port including a first pair of legs, according to some embodiments; FIG. FIG. 2 provides a schematic diagram showing a side view of a streamlined port including a first pair of legs, according to some embodiments; FIG. FIG. 4 provides a schematic diagram showing a top view of a streamlined port including a first pair of legs, according to some embodiments; FIG. FIG. 5 provides a schematic diagram showing a bottom view of a streamlined port including a first pair of legs, according to some embodiments; FIG. FIG. 4 provides a schematic diagram illustrating the deployment of a streamlined port with a first pair of legs from a port tunneler, according to some embodiments; FIG. 4 provides a schematic diagram showing an end view of a streamlined port including a second pair of legs, according to some embodiments; FIG. 4 provides a schematic diagram showing a side view of a streamlined port including a second pair of legs, according to some embodiments; FIG. FIG. 4 provides a schematic diagram showing a top view of a streamlined port including a second pair of legs, according to some embodiments; FIG. FIG. 5 provides a schematic diagram showing an end view of a streamlined port including a third pair of legs, according to some embodiments; FIG. 5 provides a schematic diagram showing a side view of a streamlined port including a third pair of legs, according to some embodiments; FIG. FIG. 4 provides a schematic diagram showing a top view of a streamlined port including a third pair of legs, according to some embodiments; FIG. FIG. 4 provides schematic diagrams illustrating the deployment of a streamlined port with a second pair of legs from a port tunneler, according to some embodiments; FIG. FIG. 2 provides a schematic diagram showing an end view of a streamlined port including a winged-type configuration, according to some embodiments; FIG. FIG. 2 provides a schematic diagram showing a side view of a streamlined port including a winged grenades shape, according to some embodiments; FIG. FIG. 2 provides a schematic diagram showing a top view of a streamlined port including a winged grenades shape, according to some embodiments; FIG. FIG. 4 provides a schematic diagram showing an end view of a streamlined port including an inflatable portion, according to some embodiments; FIG. FIG. 2 provides a schematic diagram showing a side view of a streamlined port including an inflatable portion, according to some embodiments; FIG. 9A and 9B provide schematic diagrams illustrating a system including the streamlined port and port tunneler of FIGS. 9A and 9B, according to some embodiments; FIG. 2 provides a schematic diagram showing a port tunneler including a handle, according to some embodiments; FIG. FIG. 1 provides a schematic diagram showing a set of sequential dilators for a tunneling implantation procedure, according to some embodiments; FIG. FIG. 2 provides schematic diagrams showing a tension extraction procedure using a port retriever, according to some embodiments; FIG. 1 provides a schematic diagram showing a port collector including a collet, according to some embodiments; FIG. 2 provides a schematic diagram showing a port collector in a recovery state, according to some embodiments; FIG. FIG. 4 provides a schematic diagram showing a port collector in a withdrawn state, according to some embodiments; FIG. FIG. 2 provides a schematic diagram showing an installation tool, according to some embodiments; FIG.

Before providing some specific embodiments in more detail, it should be understood that the specific embodiments provided herein do not limit the scope of the concepts provided herein. be. Certain embodiments provided herein can be readily separated from and optionally combined with features of any of the multiple other embodiments provided herein. or may have features that can be used in place of those features.

Regarding the terminology used herein, it should also be understood that the terminology is for the purpose of describing some particular embodiments and is not intended to limit the scope of the concepts provided herein. Unless otherwise indicated, sequential or numerical limitations (e.g., first, second, third, etc.) are used to distinguish or identify different features or steps in a group of features or steps and do not imply sequential or numerical limitations. does not provide For example, the "first," "second," and "third" features or steps do not necessarily appear in that order, and a particular embodiment including such features or steps necessarily includes three features or steps. need not be limited. Unless otherwise indicated, "left", "right", "front", "back", "top", "bottom", "forward", "reverse", "clockwise", "counterclockwise" , "superior", "lower" or other similar terms such as "superior", "inferior", "posterior", "anterior", "vertical", "horizontal", "proximal", "distal", etc. Any notation of is used for convenience and is not intended to imply any particular fixed position, orientation, or orientation, for example. Instead, such notations are used to reflect relative position, orientation, or direction, for example. It should also be understood that the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. .

With respect to "proximal", for example, the "proximal portion" or "proximal portion" of the catheter is the portion of the catheter that is intended to be near the clinician when the catheter is being used on a patient. including. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is being used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is being used on a patient. A proximal portion, proximal portion, or proximal length of a catheter may, but need not, include the proximal portion of the catheter. That is, unless the context indicates otherwise, a proximal portion, proximal portion, or proximal length of a catheter is not a distal portion or length of a catheter.

With respect to "tip", for example, the "distal portion" or "tip portion" of a catheter is the portion of the catheter that is intended to be near or within the patient when the catheter is being used on the patient. including. Similarly, for example, the "tip length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is being used on the patient. For example, the "tip" of a catheter includes the end of the catheter that is intended to be near or within the patient when the catheter is being used on the patient. A distal portion, tip portion, or tip length of a catheter may, but need not, include the tip of the catheter. That is, unless the context indicates otherwise, a distal portion, tip portion, or tip length of a catheter is not a distal portion or length of a catheter.

A "streamlined port" as used herein means that the port is separated from the access site, e.g., under the patient's skin, when the port moves from one location to another within the patient's body. It includes contours or contours configured to minimize resistance as it is tunneled subcutaneously to its final destination site. The profiles or profiles of the streamlined ports described herein include, but are not limited to, bullet, pill, or wedge shapes, and are generally elongated. In some embodiments, the tips of the streamlined ports described herein have a distal tip to facilitate direct tunneling through loose connective tissue or subcutaneous tissue from one location of the port to another. It tapers towards the In some embodiments, the tip of the streamlined port is rounded for tunneling through the sheath from one location of the port to another location.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.
A standard procedure to place a vascular access device such as a port requires two incisions. a first incision near the clavicle used to introduce a catheter into the superior vena cava for vascular access; and a second incision below the . Creation and closure of port pockets constitutes the majority of the procedure (approximately 42%) and increases the risk of tissue trauma and infection at the site of the second incision. Additionally, the need for a second incision increases the likelihood of scarring.

Provided herein are port tunneling systems and methods that address the above. The port tunneling system, in some embodiments, comprises a streamlined port configured to be introduced at a first incision site and a port delivery system configured to subcutaneously tunnel the port to a second implantation site or Includes a "port tunneler" and a port retrieval system or "port retriever" configured to retrieve a port from a second implantation site through a first incision site. Such a port tunneling system and method of locating the ports eliminates the need for a second incision to create a port pocket and embed the port therein. This reduces the procedural time of port placement, reduces tissue trauma, and reduces the risk of infection at the second site. Additionally, eliminating the secondary incision has cosmetic benefits to the patient in terms of reduced scarring.

Referring now to FIG. 1, a schematic diagram is provided showing a port tunneling system 1000 including a streamlined port 1100 and a port tunneler 1200 according to some embodiments. Before addressing specific features of any port tunneling system or components thereof (e.g., streamlined ports, port tunnelers, port collectors, installation fixtures, etc.), the port tunneling system 1000 of FIG. It deals with some general features and thus provides a general description of the concepts presented herein. Accordingly, some port tunneling systems may not include one or more of the global features. Port collectors and installation tools, which are also part of the port tunneling system, will be dealt with later.

A streamlined port, such as streamlined port 1100, is a percutaneous port that includes a septum and stabilizing elements to stabilize the port in vivo. (See, eg, septa 3110, 5110, 6110, and 8110 and stabilizing elements 3120, 5120, 6120, and 8120 in FIGS. 3A-3D, 5A-5C, 6A-6C, 8A-8C. A septum is positioned over the chambered cavity in the body of the port to receive a needle passing through the septum, thereby providing needle access to one or more chambers of the cavity. Configured. The stabilizing element is expandable or static and is configured to stabilize the port in vivo and maintain needle access to the septum and one or more chambers of the port. Additionally, the port includes a sufficiently small profile to subcutaneously tunnel the port on the port tunneler from the incision site to the implantation site for the port (eg, upper chest). The small profile resembles a bullet, pill, or wedge in shape, depending on the particular embodiment, but the port is generally elongated.

A port tunneler, such as port tunneler 1200, includes an adapter, such as adapter 1210, and a release mechanism that releases the streamlined port from the adapter. (See, eg, adapter 7210 in FIG. 7.) The adapter is at or at the tip of the port tunneler. The adapter is configured to securely hold the port during subcutaneous tunneling of the port from an incision site to an implantation site for the port. A release mechanism is configured to release the port from the adapter at the implantation site for the port.

A port tunneler, such as port tunneler 1200, can be configured to be placed within a sheath with a catheter, such as catheter 1130, connected to a streamlined port, such as streamlined port 1100 as shown in FIG. By releasing the port from the adapter via the release mechanism of the port tunneler, the catheter is released and slid out of the sheath when the port tunneler is withdrawn from the patient's body and ultimately through the patient's incision site. The sheath may be a pull away sheath configured such that the catheter is withdrawn through the sheath when pulled apart. This is useful when the end of the catheter opposite the port is placed, for example, in the superior vena cava before tunneling the port subcutaneously to the implantation site. However, the catheter can be placed either before or after tunneling the port subcutaneously to the implantation site. Moreover, the use of a sheath is not required, as the port tunneler 1200 loaded with streamlined port 1100 and catheter 1130 can directly follow a guidewire in place.

A port tunneler, such as port tunneler 1200, may also include a handle, such as handle 1230, at or at the proximal portion of the port tunneler. (See also FIGS. 11A and 11B (FIG. 11).) The handle includes a release device (e.g., release button 1232, trigger, switch, etc.) of a release mechanism that, when the release device is actuated, releases the adapter. is configured to release a streamlined port, such as streamlined port 1100, from. As shown in FIG. 1, for example, the handle 1230 includes a release button 1232 which, when depressed, is configured to push the deployment rod of the release mechanism to separate the port from the adapter.

Having addressed some general features of port tunneling systems, we now turn to some specific features of port tunneling systems, such as specific features of streamlined ports, port tunnelers, port collectors, and installation fixtures. deal. However, certain embodiments, such as, but not limited to, any one of the streamlined ports of FIG. It should be understood that there may be features that can be combined with features or used in place of such features.

Referring now to FIG. 2, a schematic diagram is provided showing multiple streamlined ports according to various embodiments. The multiple ports include ports 2102, 2104, 2106, 2108, 3100, 5100, and 8100, as shown.

Each streamlined port is configured to be inserted through a puncture at a location such as an internal jugular vein access site and deployed at the implantation site, for example, by tunneling the port subcutaneously through the upper chest. Accordingly, each port includes contours configured to use the port as the leading edge of a port tunneler, deliver the port through the introducer sheath, or both. The tunneling tip of the port body can be configured to be sharp to tunnel directly at the port tunneler or along a wire, or blunt to be delivered through the introducer sheath.

Each streamlined port also includes at least one expandable or static stabilizing element configured to provide stability to the port in vivo (eg, within the port pocket at the implantation site). Such stabilizing elements include, but are not limited to, one or more stabilizing elements selected from legs (or wires), wings, inflatable elements, and the shape of the port itself; The element is deployable after establishing a port pocket for implantation. Additionally, the legs can be of an open-cell design, thus allowing the port to be pulled through the connective tissue during the extraction procedure without tearing the tissue. These stabilizing elements are configured to stabilize their respective ports by preventing the ports from rotating about their central axis in vivo. For example, ports can include deployable legs such as ports 2102, 2104, 2106, 3100, or 5100, or can include wings such as port 8100. FIG.

These stabilizing elements are configured for different implantation and extraction procedures using different instruments, some of which are standard surgical instruments (e.g., forceps, pliers, etc.), some of which are are included in port tunneling systems such as port collectors configured to engage hooks, holes, or undercuts in streamlined ports. For example, ports with deployable legs that open toward the proximal end of the port or away from the tunneling tip of the port (e.g., ports 2102, 2104, and 2106) provide an incision at the internal jugular vein access site. It is configured to be implanted using a port tunneler or a series of dilator sets through the section. Similarly, a port 2108 with deployable legs that open toward the proximal end of the port is delivered along the wire as shown by the wire entering the tip of port 2108 and exiting through the side of the tip. configured as Extraction of such a port is accomplished using a port retriever (eg, port retriever 1500 (15000) of FIGS. 15A and 15B for port 2104) or sheath through a second incision in the upper chest. In another example, a port with deployable legs that open away from the proximal end of the port or toward the tunneling tip of the port (e.g., port 5100) can be used for a single injection at an internal jugular vein access site. It is configured to be implanted and extracted using at least a set of serial dilators through an incision.

In view of the above, the streamlined port 2102 is configured for tunneling implantation procedures, e.g., through a first incision in the internal jugular vein access site, and tension extraction procedures, e.g., through a second incision in the upper chest. and the extraction procedure does not require retraction of the stabilizing leg pair. Streamlined port 2104 is similarly configured for tunneling implantation procedures through the first incision, but is further configured for sheath-assisted extraction procedures in which the stabilizing leg pair is passed through the sheath. Retracted by the hook of a port retriever (eg, port retriever 1500 (15000) of FIGS. 15A and 15B) that pulls on the port. Each of streamlined ports 2106 and 3100 includes a retractable stabilizing element (see, eg, FIG. 3D), which is a pair of legs when expanded. Port 3100 is configured with a blunt tip for sheath assisted implantation procedures and port 2106 is configured with a sharper tip for tunneling implantation procedures. Streamlined port 5100 is configured with a blunt tip, for example, for sheath-assisted implantation procedures through an incision at an internal jugular access site and extraction procedures through the same internal jugular access site. Streamlined port 8100 is configured for tunneling implantation procedures and extraction procedures using standard surgical forceps or pliers like port 2102; ports 2102 and 8100 are provided herein for extraction. No port collector is required. Therefore, the port may be configured as one, such as a blunt tip or tunneling (e.g. along a wire) tip for sheath-assisted implantation procedures, a sharp tip for implantation procedures, legs (or wires), wings, and the shape of the port itself. or multiple stabilizing elements, directionality of one or more stabilizing elements for implantation and extraction through a single incision or two different incisions and one or more port retrievers (e.g., Fig. 15A and 15B) can be configured with any combination of a number of features selected from additional features such as hooks, holes, or undercuts for retrieval by the port retriever 1500 (15000) of FIGS. 15A and 15B). . The ports in FIG. 2 are examples showing these different combinations.

Each streamlined port includes a septum having a shape and configuration similar to existing non-streamlined ports. For example, a septum has a surface area comparable to existing non-streamlined ports. In contrast to existing non-streamlined ports, the port body has optional port identification projections (e.g., power port identification projections for streamlined power ports) or septum identification projections, thus reducing septum surface area for needle access. maximize. However, such port-identifying projections and septum-identifying projections are not limited to placement on the port body. A port-identifying protrusion and a septum-identifying protrusion can be included on the septum in some embodiments.

Each streamlined port may be radiopaque, MRI-ready, or MRI-ready, or a combination thereof.
Each sleek port can further include a radio frequency identification (“RFID”) tag. The port's RFID tag can contain readable information that was written to the RFID tag at the time the port was manufactured. The readable information may identify the type of port by its model number, lot number, date of manufacture, and the like. Additionally, the port's RFID tag may be writable so that patient information can be written to the RFID tag.

Each streamlined port can be press fit, welded, bonded, or threaded to form the port body, or printed using metal 3D printing. The septum is symmetrical and can be attached by various pressure-installed fittings, optionally with additional adhesive or thermal bonding. A stabilizing leg (or wire) matching stabilizing element is secured to the port body for an implantation or extraction procedure, or to deliver or retract stability for an implantation or extraction procedure. can be moved to

3A-3D, schematic diagrams are provided showing views of a streamlined port 3100 including a first pair of legs 3120 according to some embodiments. As shown, port 3100 includes a septum 3110 and a first pair of legs 3120 . A first pair of legs 3120 includes a first leg 3120a and a second leg 3120b. Also shown at least in FIGS. 3B and 3C is catheter 3130 connected to port 3100 by catheter lock 3132 . The port 3100 includes retractable stabilizing elements, which are the first pair of legs 3120 when expanded. Port 3100 is configured for at least sheath assisted implantation procedures.

The septum 3110 of the streamlined port 3100 faces the first pair of legs 3120, but is uniquely positioned at the distal end of the port 3100, as exemplified by port 1200 (9100) in FIGS. 9A and 9B. can be done. This unique placement of the septum at the distal end of port 3100 is a result of port 3100 requiring only a single incision to introduce, tunnel, and position port 3100 at the implantation site. By eliminating the secondary incision commonly used to place the port, trauma, risk of infection, and scarring at what would have been the secondary incision is reduced, thus reducing the risk of injury at the tip of port 3100. The area is freed for injection through the uniquely placed septum 3110 .

The first pair of legs 3120 of the streamlined port 3100 is an example of a stabilizing element for a streamlined port provided herein, the first pair of legs 3120 centering the port 3100 in vivo. It is configured to stabilize against rotation about an axis, thus maintaining needle access to the septum 3110 . A first pair of legs 3120 of the port 3100 assume a collapsed state while within the port tunneler's adapter (or introducer sheath) and an expanded or deployed state while outside the port tunneler's adapter (or introducer sheath). is configured to exhibit The expanded state of the first pair of legs 3120 stabilizes the port 3100 against rotation about the central axis of the port 3100 in vivo, thus maintaining needle access to the septum 3110 .

In the collapsed state of the first pair of legs 3120, each leg of legs 3120a and 3120b lies along its own side of the body of streamlined port 3100 and is held in place by the adapter (or introducer sheath) of the port tunneler. is held to The folded state of the first pair of legs 3120 allows the port 3100 to initially assume a low profile for subcutaneously tunneling the port 3100 on the port tunneler from the incision site to the implantation site. That is, the first pair of legs 3120 provide or otherwise provide a sufficiently small profile of the port 3100 to subcutaneously tunnel the port 3100 from the incision site to the implantation site for the port 3100 . Contains contributing folded states.

In the expanded state of the first pair of legs 3120 , each leg of legs 3120 a and 3120 b is configured via shape memory to project from the proximal end of the body of streamlined port 3100 . The expanded state of the first pair of legs 3120 allows the port 3100 to later assume a larger profile to secure the port 3100 at the implantation site and maintain needle access to the septum 3110 . That is, the first pair of legs 3120 are in an expanded state configured to stabilize the port 3100 against rotation about the central axis of the port 3100 in vivo, thus maintaining needle access to the septum 3110. including.

Legs 3120a and 3120b may join to form a "U" shape at the distal end of streamlined port 3100, as best shown in FIG. 3D. Each leg of legs 3120a and 3120b is anchored and retained by its own leg retainer (eg, a hole through the body extension of port 3100), so in some embodiments, the U The pair of legs 3120 of the letter-shaped can slide longitudinally along the body of the port 3100 . The shape memory of the leg pair 3120 shortens the proximal leg pair of the leg retainer by sliding the U-shaped leg pair 3120 toward the distal end of the port 3100 . , their chip-to-chip width becomes narrower. Sliding the U-shaped leg pair 3120 toward the proximal end of the port 3100 lengthens the proximal leg pair of the leg retainer and widens their tip-to-tip width. . This is useful for adjusting the chip-to-chip width of leg pairs 3120 of port 3100 for different sized implant sites.

Referring now to FIG. 4, a schematic diagram is provided illustrating deployment of a streamlined port 3100 having a first pair of legs 3120 from a port tunneler 4200, according to some embodiments. During the tunneling implantation procedure, port 3100 and leg pair 3120 are housed within port tunneler 4200 or an adapter at the tip of port tunneler 4200 . (See, e.g., adapter 7210 in FIG. 7.) Port tunneler 4200 thus deploys leg pair 3120 until port 3100 emerges from port tunneler 4200 at the implant site (e.g., port pocket) for port 3100. restrain from doing. When releasing the port 3100 from the port tunneler 4200 with the release mechanism, the first pair of legs 3120 are configured to assume a deployed condition.

5A-5C, schematic diagrams are provided showing views of a streamlined port 5100 including a second pair of legs 5120, according to some embodiments. As shown, port 5100 includes a septum 5110 and a second pair of legs 5120 . A second pair of legs 5120 includes a first leg 5120a and a second leg 5120b. 5B and 5C also show catheter 5130 connected to port 5100 by catheter lock 5132. FIG. Port 5100 is configured with a second pair of distally opening legs 5120 for at least sheath assisted implantation procedures at the internal jugular vein access site and extraction procedures through the access site.

The septum 5110 of the streamlined port 5100 faces the second pair of legs 5120, but is uniquely positioned at the distal end of the port 5100, as illustrated by port 1100 (9100) in FIGS. 9A and 9B. can be done. Again, the unique placement of the septum at the tip of these streamlined ports is a result of the port requiring only a single incision to introduce, tunnel, and position the port at the implantation site. is.

The second pair of legs 5120 of the streamlined port 5100 is another example of a stabilizing element for a streamlined port provided herein, and the second pair of legs 5120 can be used to support the port 5100 in vivo. is configured to stabilize against rotation about its central axis, thus maintaining needle access to septum 5110 . A second pair of legs 5120 of the port 5100 assumes a collapsed state while within the port tunneler's adapter (or introducer sheath) and a deployed state while outside the port tunneler's adapter (or introducer sheath). configured as The expanded state of the second pair of legs 5120 stabilizes the port 5100 against rotation about the central axis of the port 5100 in vivo, thus maintaining needle access to the septum 5110 .

In the collapsed state of the second pair of legs 5120, each leg of legs 5120a and 5120b lies along its own side of the body of streamlined port 5100 and is held in place by the adapter (or introducer sheath) of the port tunneler. is held to The folded state of the second pair of legs 5120 allows the port 5100 to initially assume a low profile for subcutaneously tunneling the port 5100 on the port tunneler from the incision site to the implantation site. That is, the second pair of legs 5120 provide or otherwise provide a sufficiently small profile of the port 5100 to subcutaneously tunnel the port 5100 from the incision site to the implantation site for the port 5100 . Contains contributing folded states.

In the expanded state of the second pair of legs 5120 , each leg of legs 5120 a and 5120 b is configured via shape memory to protrude from the distal end of the body of streamlined port 5100 . The expanded state of the second pair of legs 5120 allows the port 5100 to later assume a larger profile to secure the port 5100 at the implantation site and maintain needle access to the septum 5110 . That is, the second pair of legs 5120 are in an expanded state configured to stabilize the port 5100 against rotation about the central axis of the port 5100 in vivo, thus maintaining needle access to the septum 5110. including.

Each leg of legs 5120a and 5120b is anchored and retained by its own leg retainer (eg, a hole through the body extension of port 5100), thus, in some embodiments, the legs Each leg of portions 5120 a and 5120 b is individually and longitudinally slidable along the body of streamlined port 5100 . Due to the shape memory of each leg of legs 5120a and 5120b, sliding the first leg, such as leg 5120a, toward the proximal end of port 5100 causes the distal leg of the leg retainer to move. is shortened, and the chip-to-chip width with the second leg such as the leg 5120b is narrowed. By sliding the first leg toward the distal end of the port 5100, the leg on the distal side of the leg holding portion is lengthened and the width between the chips with the second leg is widened. Not only is this useful for adjusting the tip-to-tip width of leg pair 5120 in the expanded state of port 5100 for different sized implant sites, but each leg of legs 5120a and 5120b can be adjusted individually. Adjustments also allow fine tuning of the expansion state.

The streamlined ports 3120 and 5120 of FIGS. 3A-3D and 5A-5C, respectively, differ at least in the placement of their leg retainers and the joining of their leg pairs. Again, the port 5100 is configured with a second pair of legs 5120 that open distally for at least sheath-assisted implantation procedures at the internal jugular vein access site and extraction procedures through the access site. . However, the leg retainers in the body of streamlined port 3120 can be located at the proximal end of the body of port 3120 (as in port 5120) instead of at the distal end of the body. Further, legs 5120a and 5120b are not joined or instead of being separated, are "U" shaped (like first pair 3120 of legs of port 3120) at the proximal end of streamlined port 5100. It can be joined to form a shape. Again, the specific embodiments provided herein are examples and do not limit the scope of the concepts provided herein.

6A-6C, schematic diagrams are provided showing views of a streamlined port 6100 including a third pair of legs 6120, according to some embodiments. As shown, port 6100 includes a septum 6110 and a third pair of legs 6120 . A third pair of legs 6120 includes a first leg 6120a and a second leg 6120b. Also shown in FIGS. 6B and 6C is catheter 6130 connected to port 6100 by catheter lock 6132 .

The septum 6110 of the streamlined port 6100 faces the third pair of legs 6120, but is uniquely positioned at the distal end of the port 6100, as exemplified by port 1100 (9100) in FIGS. 9A and 9B. can be done. Again, the unique placement of the septum at the tip of these streamlined ports is a result of the port requiring only a single incision to introduce, tunnel, and position the port at the implantation site. is.

The third pair of legs 6120 of the streamlined port 6100 is another example of a streamlined port stabilizing element provided herein, the third pair of legs 6120 supporting the port 6100 in vivo. is configured to stabilize it against rotation about its central axis, thus maintaining needle access to the septum 6110 . A third pair of legs 6120 of the port 6100 assumes a collapsed state while within the port tunneler's adapter (or introducer sheath) and an expanded or deployed state while outside the port tunneler's adapter (or introducer sheath). is configured to exhibit The extended state of the third pair of legs 6120 stabilizes the port 6100 against rotation about the central axis of the port 6100 in vivo, thus maintaining needle access to the septum 6110 .

In the collapsed state of the third pair of legs 6120, each leg of legs 6120a and 6120b lies along its own side of the body of streamlined port 6100 and is held in place by the adapter (or introducer sheath) of the port tunneler. is held to The folded state of the third pair of legs 6120 allows the port 6100 to initially assume a low profile for subcutaneously tunneling the port 6100 on the port tunneler from the incision site to the implantation site. That is, the third pair of legs 6120 provide or otherwise provide a sufficiently small profile of the port 6100 to subcutaneously tunnel the port 6100 from the incision site to the implantation site for the port 6100. Contains contributing folded states.

In the expanded state of the third pair of legs 6120, each leg of legs 6120a and 6120b has a shape memory such that it bows at a proximal portion of the body of streamlined port 6100 or from a proximal portion to an intermediate portion of the legs. Configured via The expanded state of the third pair of legs 6120 allows the port 6100 to later assume a larger profile to secure the port 6100 at the implantation site and maintain needle access to the septum 6110 . That is, the third pair of legs 6120 are in an expanded state configured to stabilize the port 6100 against rotation about the central axis of the port 6100 in vivo, thus maintaining needle access to the septum 6110. including.

Each leg of legs 6120 a and 6120 b is anchored and retained by its own leg retainer (eg, a hole through the body extension of port 6100 ) and is secured to the body of streamlined port 6100 . The shape memory of each leg of legs 6120a and 6120b allows each leg to move from the proximal portion of the body of port 6100 or from the proximal end to the intermediate portion of the leg as soon as the streamlined port is released from the adapter of the port tunneler. It bends like a bow at As such, the port 6100 may instead be configured such that the third pair of legs 6120 bow from the distal portion or distal end of the body of the port 6100 similar to the streamlined port 5100 of FIGS. 5A-5C. can be done. The bent intermediate portions of leg pair 6120 form a compressible spring with a spring rate that expands port 6100 to accommodate implant sites of different sizes in the expanded state. Additionally, the spring rate is sufficient to secure port 6100 at the implantation site without causing trauma.

Referring now to FIG. 7, a schematic diagram is provided showing deployment of a streamlined port 6100 with a third pair of legs 6120 from a port tunneler, according to some embodiments. During the tunneling implantation procedure, port 6100 and leg pair 6120 are housed within adapter 7210 at the tip of the port tunneler. Thus, the adapter 7210 inhibits the leg pair 6120 from deploying until the port 6100 emerges from the port tunneler's adapter 7210 at the implant site (eg, port pocket) for the port 6100 . When the release mechanism releases the port 6100 from the port tunneler adapter 7210, the first pair of legs 6120 is configured to assume a deployed state.

8A-8C, schematic diagrams are provided showing views of a streamlined port 8100 including a pair of wings 8120, according to some embodiments. As shown, port 8100 includes a septum 8110 facing a pair of wings 8120 . The wing pair 8120 includes a first wing 8120 a and a second wing 8120 b that provide a winged shape to the port 8100 . 8B and 8C also show catheter 8130 connected to port 8100 by catheter lock 8132. FIG. The port 8100 is configured for at least tunneling implantation and extraction procedures with standard surgical forceps or pliers, i.e., the 8100 does not require the port retriever provided herein for extraction.

The septum 8110 of the streamlined port 8100 faces the wing pair 8120, but can be uniquely positioned at the distal end of the port 8100, as exemplified by port 1100 (9100) in FIGS. 9A and 9B. . Again, the unique placement of the septum at the tip of these streamlined ports is a result of the port requiring only a single incision to introduce, tunnel, and position the port at the implantation site. is. However, because the port 8100 has a more pronounced or sharper tip than some of the other streamlined ports provided herein, such changes to the tip of the port 8100 give the port 8100 a less pronounced bullet-shaped shape. becomes.

The wing pair 8120 of the streamlined port 8100 is another example of a streamlined port stabilizing element provided herein, the wing pair 8120 aligning the port 8100 with the central axis of the port 8100 in vivo. It is configured to stabilize against pivoting, thus maintaining needle access to the septum 8110 . Due to the fact that the wing pairs 8120 can stabilize the port in vivo, along with the already low profile of the port 8100, the port 8100 need not include a collapsed and expanded state. As such, each wing of wing pair 8120 may be disposed over a spring element within the wing cavity in the body of port 8100 in some embodiments. Like leg pair 6120 of streamlined port 6100, each wing pops out of its cavity to transition port 8100 from a collapsed state to an expanded state as soon as streamlined port 8100 is released from the port tunneler's adapter. . This is useful for expanding the footprint of port 8100 if desired.

9A, 9B, and 10 are illustrations of a streamlined port 9100 including an inflatable portion 9120 as a stabilizing element and a port tunneler 10200 for the port 9100, according to some embodiments. An illustrative schematic is provided.

As shown in FIG. 10, port tunneling system 10000 including streamlined port 9100 and port tunneler 10200 is configured with an expansion mechanism positioned between port 9100 and port tunneler 10200 . The inflation mechanism allows the port 9100 to initially assume a low profile for subcutaneous tunneling of the port 9100 on the port tunneler 10200 from the incision site to the implantation site. The inflation mechanism also allows the port 9100 to later assume a larger profile to secure the port 9100 at the implantation site and maintain needle access to the septum of the port 9100 .

With respect to the port tunneler 10200 of FIG. 10, the port tunneler 10200 includes an inflation lumen 10222 located within the inflation tube, a first fitting or hub 10224 at the proximal end of the inflation tube, and a second fitting at the distal end of the inflation tube. each of which is considered part of the inflation mechanism. The inflation tube or its inflation lumen 10224 provides one or more fluids to both the fluid source(s) (eg, a syringe containing one or more fluids) and the inflatable portion of the streamlined port 9100. is configured to be fluidly connected to inflate the inflatable portion by. A first fitting or hub 10224 at the proximal end of the inflation tube is configured as a female luer taper fitting that receives a corresponding male luer taper fitting of the syringe 1001 to deliver one or more fluids to the inflation lumen 10222. can be done. Such luer taper fittings may be slip-type or lock-type luer taper fittings. A second fitting at the distal end of the inflation tube may be a male or female fitting in any of a number of ways to connect the inflation tube or its inflation lumen 10222 to the inflatable portion of port 9100 through the opening of port 9100. Configurable, the opening includes a fitting corresponding to a second fitting of the inflation tube.

With respect to port 9100 of FIGS. 9A and 9B, port 9100 includes septum 9110 and inflatable portion 9120 . Also shown in FIGS. 9A and 9B is catheter 9130 connected to port 9100 by catheter lock 9132 . The septum 9110 of the streamlined port 9100 can be uniquely positioned at the distal end of the port 9100, as shown in Figures 9A and 9B. This unique placement of septum 9110 at the distal end of port 9100 is a result of port 9100 requiring only a single incision to introduce, tunnel, and position port 9100 at the implantation site. . By eliminating the secondary incision commonly used to place the port at the implantation site, trauma, risk of infection, and scarring at what would have been the secondary incision are reduced, thus reducing port 9100's risk of injury. A region is freed for injection through a uniquely placed septum 9110 at the tip. As such, the port 9100 can instead include a septum 9110 opposite the inflatable portion 9120 of the port 9100 .

Due to the inflation mechanism located between the streamlined port 9100 and the port tunneler 10200, the port 9100 assumes an initial low profile for subcutaneous tunneling of the port 9100 on the port tunneler 10200 from the incision site to the implantation site, and the implantation site. A large profile can be later assumed to secure the port 9100 at the septum 9110 and maintain needle access to the septum 9110 . The inflatable portion 9120 of the streamlined port 9100 is another example of a streamlined port stabilizing element provided herein, wherein the inflatable portion 9120 moves the port 9100 about the central axis of the port 9100 in vivo. It is configured to stabilize against rotation and thus maintain needle access to the septum 9110 .

An expansion mechanism positioned between the streamlined port 9100 and the port tunneler 10200 allows the port 9100 to initially assume a low profile for subcutaneously tunneling the port 9100 on the port tunneler 10200 from the incision site to the implantation site. . Inflatable portion 9120 of port 9100 included as part of the inflation mechanism of port tunneling system 10000 allows for a low profile of port 9100 due to the uninflated state of inflatable portion 9120 . That is, the inflatable portion 9120 does not provide or otherwise contribute to a sufficiently small profile of the port 9100 to subcutaneously tunnel the port 9100 from the incision site to the implantation site for the port 9100. Includes inflated state.

With an expansion mechanism located between the streamlined port 9100 and the port tunneler 10200, the port 9100 can later assume a larger profile to further secure the port 9100 at the implantation site and maintain needle access to the septum 9110. can. Inflatable portion 9120 of port 9100 allows for a large profile of port 9100 depending on the expanded state of inflatable portion 9120 . That is, inflatable portion 9120 further includes an expanded state configured to stabilize port 9100 against rotation about a central axis of port 9100 in vivo, thus maintaining needle access to septum 9110. . In the inflated state of inflatable portion 9120 , inflatable portion 9120 imparts a triangular prism-like shape to at least a portion of port 9100 . For example, the middle portion of port 9100 can resemble a triangular prism when inflatable portion 9120 is in the inflated state. The cross section of such a triangular prism is triangular.

Inflatable portion 9120 of port 9100 can be configured to inflate with one or more fluids. One or more fluids can be delivered to the inflatable portion 9120 by a syringe (eg, syringe S in FIG. 10) through the inflation lumen 10222 of the port tunneler 10200, the one or more fluids comprising: It is selected from mixtures including pure fluids and solutions. Pure fluids can include gases such as nitrogen or argon, liquids such as water, or combinations thereof. The mixture can include a gas such as air, a liquid such as mineral oil, saline, or a solution or solutions of one or more polymers or polymer precursors, or combinations thereof.

For one or more solutions of polymers or polymer precursors, the expandable portion 9120 can be configured to expand by introducing the solution into the expandable portion 9120 via a syringe, the solution containing at least one polymer. It includes a precursor (eg, polymer precursor A) that forms a polymer with at least one other polymer precursor (eg, polymer precursor B) after polymerization and cross-linking within expandable portion 9120 . At least one other polymer precursor (e.g., polymer precursor B) is placed within expandable portion 9120 during manufacture or prior to the solution containing at least one polymer precursor (e.g., polymer precursor A). or can be introduced into the inflatable portion 9120 at a later time. The expansion of the expandable portion 9120 comprises introducing one or more of the solutions of polymer precursors into the expandable portion 9120 for a first expansion of the expandable portion 9120, followed by at least one polymer precursor ( allowing polymer precursor A) and at least one other polymer precursor (e.g., polymer precursor B) to polymerize and crosslink in the second expansion of expandable portion 9120. be able to. As such, the first and second expansions of the inflatable portion 9120 can occur simultaneously, and the first and second expansions of the inflatable portion 9120 can be coextensive. Expansion of the expandable portion 9120 can further include application of a low biocompatible amount of heat for polymerization, cross-linking, or both polymerization and cross-linking. Crosslinking cures the polymer within the expandable portion 9120 .

Inflatable portion 9120 of port 9100 can be configured to be inflated by one or more polymers, optionally in combination with one or more of the fluids described above. The one or more polymers can be one or more swellable polymers placed within the expandable portion 9120 during manufacture. Inflatable portion 9120 may be expanded by introducing one or more of the fluids (e.g., water, saline, etc.) described above into inflatable portion 9120 for a first inflation of inflatable portion 9120 and subsequently inflating. In combination with allowing the one or more swellable polymers to swell in the presence of the one or more fluids in the second inflation of the enabling portion 9120 can be configured to expand. As such, the swelling kinetics of the one or more swellable polymers may be such that the first and second swellings of the expandable portion 9120 occur simultaneously. Additionally, the first and second expansions of the inflatable portion 9120 can be coextensive.

The streamlined port 9100 can include a one-way valve configured to close the opening of the port 9100 to the inflatable portion 9120 when releasing the port 9100 from the port tunneler 10200 . The one-way valve can include a diaphragm or ball configured to abut inside the opening to the inflatable portion 9120 . The pressure of incoming inflation fluid or a male fitting at the tip of the inflation tube of port tunneler 10200 can hold the one-way valve open by displacing a diaphragm or ball. When the pressure of the incoming inflation fluid or the male fitting is removed, the internal pressure within the inflation portion 9120 of the port 9100 forces the diaphragm or ball against the opening to the inflation portion 9120, closing the one-way valve. maintained. Alternatively, the one-way valve can be a flutter valve that closes the opening of port 9100 to expansion portion 9120 when releasing port 9100 from port tunneler 10200 .

With respect to implanting the streamlined port 9100 of Figures 9A and 9B, vascular access is established at a first incision site and a catheter tip is advanced to a location such as the superior vena cava. The catheter is then trimmed and attached to port 9100 . The port 9100 is then placed over the port tunneler 10200 and tunneled subcutaneously to an implantation site such as the upper chest. An inflation solution is then injected into the inflation lumen of the port tunneler 10200 and the inflatable portion 9120 of the port 9100 is inflated to its full dimensions. Port tunneler 10200 is then removed, thus isolating port 9100 from the inflation lumen, thereby closing the one-way valve of port 9100 . The access site is then closed. Port 9100 is then accessed by a needle function to confirm proper function.

Referring now to FIG. 11, a schematic diagram is provided showing a port tunneler 11200 including a full-sized handle 11230, according to some embodiments. The handle 11230 is configured to provide the operator with a suitable grip for tunneling and positioning the streamlined port. For port tunneling, a typical tunneler can be used to initiate the initial tunneling path. Port tunneler 11200 may be configured to have sufficient bendability to follow the initial tunneling path. Additionally, as shown herein, the tunneling tip of the port body can be configured as sharp for direct tunneling with a port tunneler, such as port tunneler 11200 . As shown, port tunneler 11200 further includes release button 11232 for releasing the tunneling port from adapter 11210 . Release button 11232 is configured to push the deployment rod of the release mechanism of port tunneler 11200 to disconnect the port from adapter 11210 when release button 11232 is pressed. The port tunneler 11200 is configured to be later removed from the tunneling path without disturbing the position of a catheter already placed in, for example, the superior vena cava.

Referring now to FIG. 12, a schematic diagram is provided showing a sequential dilator set 12000 for a tunneling implantation procedure, according to some embodiments. As shown, a streamlined port such as adjustable port 1100 can be configured to be implanted by the introducer sheath 12030 of the serial dilator set 12000 . Sequential dilator set 12000 includes, but is not limited to, a typical tunneling instrument, i.e., a tunneler, an initial dilator or first dilator 12010, e.g. 12020 and a final introducer sheath 12030 of sufficient diameter to accommodate the streamlined port with stabilizing elements. A tunneling path is initiated at the incision site by an initial dilator 12010 to establish a thin-walled supportive sheath for embedding a streamlined port (eg, streamlined port 1100), the initial dilator 12010 passing through the rest of the dilator set 12000. It includes a flexible length extending from its proximal end for screwing the portion thereon. In the first stage of dilation, the second dilator 12020 is screwed over the initial dilator 12010, and the initial dilator is finally removed. A final introducer sheath is then threaded over both the second dilator 12020 and the initial dilator 12010 in the second stage of dilation. The initial dilator 12010 and secondary dilator 12020 are then removed leaving the introducer sheath 12030 in place. The port is implanted through the introducer sheath 12030 into the port pocket at the final implantation site. The introducer sheath 12030 is then withdrawn and any matching stabilizing elements of the folded legs are immediately expanded to secure the port within the port pocket in its final location. The advantage of sequential dilation with the sequential dilator set 12000 is less aggressive deployment of the incision along the implantation path and better control over the final implantation location. Additionally, if any sutures are required, only one or two sutures are required to close the incision site.

Using the tunneling path described above beginning with the initial dilator 12010, a guidewire can be placed so that the guidewire can be used to tunnel the over-the-wire streamlined port 2108 to the final implantation site.

Such a sequential dilator set facilitates tunneling of the ports during implantation to their final implantation site regardless of the extraction procedure. Additionally, such a sequential dilator set aids in jugular vein extraction procedures by advancing a first dilator and a second dilator over the tunneler.

13 and 14, schematic diagrams are provided showing a port retriever 14000 including a collet 14210 and a tension extraction procedure 13000 using the port retriever 14000, according to some embodiments. As shown, the port retriever 14000 includes a full-sized handle configured to provide the operator with a suitable grip for retrieving the streamlined port. Additionally, the handle includes a slider 14232 configured to push the final support sheath out of the collet 14210 so that the collet fingers of the collet 14210 can adequately squeeze the port for a pull extraction procedure. The port retriever 1400 (14000) is configured to retrieve the port through the same tunneling pathway as the tunneling implantation procedure to eliminate scarring normally associated with port-to-pocket port extraction.

For a pull extraction procedure 13000 to a port, a dilator set, such as the serial dilator set 12000, is used to advance over the catheter to the tip of the port near the catheter lock. In the case of port 5100 of FIG. 13, for example, first dilator 12010 of serial dilator set 12000 goes over catheter 5130 and bottoms out at catheter lock 5132 . The second dilator 12020 goes over the first dilator 12010 and bottoms out at the catheter lock 5132 as well. After sufficient dilation has been established, a final support sheath (eg, sheath 12030 of serial dilator set 12000) is placed and port retriever 14000 is advanced down the support sheath to port 5100 and engages port 5100. match. Collet fingers of collet 14210 are configured to deflect over an angled undercut at the tip of port 5100 . Slider 14232 is configured to push the support sheath out of collet 14210 . Once engaged, port 5100 can be retracted through the support sheath to fold the second pair of legs 5120 into the support sheath.

15A and 15B, schematic diagrams are provided showing the port collector 15000 in different states of use, according to some embodiments. As shown, the port retriever includes a handle 15330, a port scoop 15310, and a port hook 15312, with Figure 15A showing the port retriever 15000 in the retracted state and Figure 15B showing the port retriever in the retracted state. 1500 (15000) is shown. The recovery state of port collector 1500 (15000) is configured to hook a port, such as port 2104 in FIG. Once the port is hooked, the handle 15330 can be closed to form the withdrawn condition of the port collector 15000 . In doing so, the port is raised over the port scoop 15310, thus retracting any deployed stabilizing element of any counterpart of the leg. Additionally, once the handle is closed, the snap tab or detent prevents the handle from reopening, thus preventing accidental redeployment of the port when the port retriever 15000 is withdrawn. Such port retrieval is configured to facilitate port retrieval from, for example, the upper chest in a two-stage procedure of a port retriever.

Referring now to FIG. 16, a schematic diagram is provided showing an installation tool 16300, according to some embodiments. As shown, the installation tool 16300 is configured to hold at least a distal portion of a port such as port 3100 to connect and lock a catheter (eg, catheter 3130) to a proximal portion of the port. Includes spoon 16310. Installation tool 16300 is further configured to facilitate installation of the port within the adapter at the tip portion of the port tunneler.

For implanting the streamlined ports provided herein, the desired vessel is located and accessed with an introducer needle at the access site. The access needle is removed and replaced with a guidewire. An introducer is advanced along the guidewire. Accurate guidewire position is confirmed via fluoroscopy, depth measurements on the guidewire are recorded, and the guidewire is removed. Alternatively, the above can be achieved by ECG guidance. The catheter for the port is then of the correct length, considering the distance from the access site, e.g., to the superior vena cava plus the desired distance from the access site to the desired port pocket location, e.g., in the upper chest. trimmed to fit. The catheter is attached to a port that can come pre-installed in the port tunneler. A port tunneler is then inserted at the access site and tunneled to the desired port pocket location. The introducer is then removed and the catheter pushed into the access site. The catheter tip is checked through fluoroscopy, after which the port is released from the port tunneler. The port tunneler is removed and the port is then accessed to confirm correct flow.

Further regarding embedding the streamlined ports provided herein, the ports can be embedded as follows. A streamlined port is loaded onto the adapter at the tip of the port tunneler. The port is inserted into an incision at a first body location, and the incision is sized to require one or no more than two sutures to close the incision. The port is subcutaneously tunneled to an implantation site at a second intracorporeal location using the tip of the port. The port is released from the adapter by the port tunneler's release mechanism. The port tunneler adapter is configured to hold the port stabilizing element in a folded state. By releasing the port from the adapter, the port's stabilizing element can assume an expanded state to stabilize the port in vivo and maintain needle access to the port's septum.

When implanting the streamlined port, the cardiac end of the catheter is also implanted in the superior vena cava. The port end of the catheter is connected to the port and locked by a catheter lock prior to loading the port onto the port tunneler's adapter. Connecting and locking the port end of the catheter onto the port either before or after implanting the cardiac end of the catheter in the superior vena cava.

The streamlined port is removed from the second body location using a port retriever. The port retriever includes a hook for withdrawing the port from the second body location through a hole in the tip of the port. Alternatively, the port is removed from the second internal body location using one or more standard surgical instruments.

Further regarding embedding the streamlined ports provided herein, the ports can be embedded as follows. An incision is formed at the first body location, the incision being sized such that no more than one or two sutures are required to close the incision. A pathway is established to the second intrabody location. A path is successively dilated using successive dilator sets. Following dilation with the dilator set, the sheath is left in place to load the streamlined port. A port is loaded into the proximal end of the sheath. The port is tunneled to an implantation site at a second intracorporeal location at the distal end of the sheath. The port is released from the distal end of the sheath. The sheath is configured to hold the stabilizing elements of the port in a folded state along the length of the sheath. By releasing the port from the sheath, the port's stabilizing element can assume an expanded state to stabilize the port in vivo and maintain needle access to the port's septum.

When implanting the streamlined port, the cardiac end of the catheter is also implanted in the superior vena cava. The port end of the catheter is connected to the port and locked to the port with a catheter lock prior to loading the port within the sheath. Connecting and locking the port end of the catheter to the port either before or after implanting the cardiac end of the catheter in the superior vena cava.

The streamlined port is removed from the second body location using a port retriever. The port retriever includes a hook for withdrawing the port from the second body location through a hole in the tip of the port. Alternatively, the port is removed from the second internal body location using one or more standard surgical instruments. Alternatively, the port is removed from the second intracorporeal location with a separate sheath along the path from the first intracorporeal location to the second intracorporeal location.

Although some specific embodiments are provided herein and certain embodiments are provided in some detail, the specific embodiments are not intended to limit the scope of the concepts presented herein. Not intended. Additional adaptations and/or modifications may become apparent to those skilled in the art, and in the broader aspects these adaptations and/or modifications are likewise encompassed. Accordingly, departures may be made from the specific embodiments provided herein without departing from the scope of the concepts provided herein.

Claims (3)

A system comprising a streamlined port and a port tunneler,
a) the streamlined port is a septum disposed over a cavity within the body of the streamlined port, the septum configured to receive a needle therethrough and the streamlined port stabilized in vivo; and a stabilizing element configured to maintain needle access to the septum;
b) the port tunneler is an adapter at the distal end of the port tunneler to hold the streamlined port fixed during subcutaneous tunneling of the streamlined port from an incision site to an implantation site for the streamlined port; and a release mechanism configured to release the streamlined port from the adapter at the implantation site, the system comprising:
the stabilizing element is an inflatable portion of the streamlined port;
The inflatable portion is
an unexpanded state that provides the streamlined port with a contour configured to subcutaneously tunnel the streamlined port from an incision site to the implantation site for the streamlined port;
an expanded state configured to stabilize the streamlined port against rotation about the central axis of the streamlined port in vivo, thus maintaining needle access to the septum;
the expandable portion is configured to expand by introducing a solution comprising at least one polymer precursor;
the at least one polymer precursor forms a polymer with at least one other polymer precursor after polymerization and cross-linking within the expandable portion;
system. A system comprising a streamlined port and a port tunneler,
a) the streamlined port is a septum disposed over a cavity within the body of the streamlined port, the septum configured to receive a needle therethrough and the streamlined port stabilized in vivo; and a stabilizing element configured to maintain needle access to the septum;
b) the port tunneler is an adapter at the distal end of the port tunneler to hold the streamlined port fixed during subcutaneous tunneling of the streamlined port from an incision site to an implantation site for the streamlined port; and a release mechanism configured to release the streamlined port from the adapter at the implantation site, the system comprising:
the stabilizing element is an inflatable portion of the streamlined port;
The inflatable portion is
an unexpanded state that provides the streamlined port with a contour configured to subcutaneously tunnel the streamlined port from an incision site to the implantation site for the streamlined port;
an expanded state configured to stabilize the streamlined port against rotation about the central axis of the streamlined port in vivo, thus maintaining needle access to the septum;
The streamlined port further comprises a one-way valve configured to close the inflatable portion when the release mechanism releases the streamlined port from the port tunneler.
system. said stabilizing element is a winged shape of said streamlined port;
the winged shape is configured to stabilize the streamlined port against rotation about the central axis of the streamlined port in vivo, thus maintaining needle access to the septum;
The system of claim 1 .

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